NEW DELHI : Gennova Biopharmaceuticals Ltd, the first Indian company to develop an mRNA vaccine for covid-19, must submit safety data of phase-3 trials across 90 days, experts at a top drug safety panel decided after the company applied to use it as a booster dose in heterologous mode.
Last year, the Pune-based company’s Gemcovac-19 was cleared for use in homologous mode, where the same shot is used for first and second doses.
Now, it plans to use the Omicron-specific vaccine as a booster in heterologous mode usage as the second dose when the first dose is Serum Institute of India Ltd’s Covishield or Bharat Biotech Ltd’s Covaxin. It has presented its proposal for the grant of permission for a Lyophilized mRNA vaccine for covid against the Omicron variant as a single booster dose. Gennova submitted phase-II clinical trial data for all 140 subjects, including safety data for up to 90 days and immunogenicity data for up to 29 days against the Omicron variant, minutes of the Drugs Controller General of India’s (DCGI) expert panel meeting showed. Its job is to review the safety data and, if found satisfactory, recommend it for a final nod to DCGI.
Gennova also presented interim phase-III data for about 3,000 subjects, including safety data for up to 29 days and immunogenicity data for 420 subjects for up to 29 days.
“The firm presented the interim clinical trial data of phase II/III heterologous booster dose and requested for submission of Phase-III safety data up to 90 days for all the subjects at the earliest. Accordingly, after detailed deliberation, the committee recommended that the firm should submit the 90 days safety data of Phase III clinical trial along with a proposed summary of product characteristics (SmPC), Package Insert (PI) and fact sheet to CDSCO for further deliberation,” the minutes read.
Traditional vaccines introduce a weakened or inactivated germ into the body, but mRNA vaccines work by instructing cells to make a protein that the immune system can recognize and respond to. The cost-effective vaccine can be quickly tweaked for existing and emerging variants.
Queries sent to spokespeople for the health ministry and Gennova remained unanswered. A person familiar with the matter said the company had submitted its response.
All covid vaccines are still licensed under “restricted use under emergency situations”, with the government urging eligible individuals to receive booster doses if not taken.
So far, India has administered 2.21 billion vaccine doses, of which only 228.7 million were precaution or booster doses.
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